Eisai will request reconsideration of initial decision for lecanemab in Australia
BioAge Labs, Inc. (BIOA)
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Source: PR Newswire
STOCKHOLM, Oct. 16, 2024 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aß) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia. Following Eisai's request for review, the TGA will issue a final decision within 60 days of receiving Eisai's request.Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel UAE and Great Britain, and is being marketed in the United States, Japan and China.Lecanemab is the result of a long-standin
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- 11/14/24 - Form SC
- 11/12/24 - Form SC
- 11/7/24 - Form 10-Q
- BIOA's page on the SEC website